Posted by Michael Wonder on 22 Apr 2021
Novartis to discontinue sales of Piqray in Germany
21 April 2021 - The sale of Piqray (alpelisib) will be discontinued by Novartis in accordance with Section 4 (7) of the framework agreement in conjunction with Section 130b (9) SGB V on 1 May 2021.
Therapy can nevertheless be continued or restarted, because according to Section 73 (1) AMG, the medicinal product can continue to be prescribed in Germany and taken from another member state of the European Union or a signatory to the European Economic Area.
The reason for the withdrawal from the market is the benefit assessment according to Section 35a of Book V of the Social Code, where alpelisib was not awarded any additional clinical benefit.
